Lantidra (donislecel) is a pancreatic islet cell therapy for type 1 diabetes obtained from pancreatic cells of deceased donors.
The American Food and Drug Administration (Fda) approved the first cell therapy for the type 1 diabetes. Developed by biotech CellTransbased in Chicago, Lantidra (donislecel) is a therapy based on pancreatic islet cells obtained from pancreatic cells deceased donors. It is authorized for adults with type 1 diabetes whose repeated episodes of hypoglycemia make them unable to reach average levels of glucose in the blood. Also called ‘fragile’ diabetes, this condition is ultra-rare, affecting three in 1,000 people with diabetes insulin dependent.
In a prepared statement, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said hypoglycemia is a dangerous condition that can lead to injury from loss of consciousness or seizures. The approval of the therapy “provides people with type 1 diabetes and recurrent severe hypoglycemia with an additional treatment option to help achieve target blood glucose levels,” Marks said.
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Lantidra is infused into the portal vein of the liver, with a second dose given to some patients depending on the response to the first infusion. Insulin secretion by the infused cells can produce enough insulin to free some patients from daily injections or a pump.
donislecel is thought to work through the secretion of insulin by the infused allogeneic beta cells. According to the FDA press release, in some patients these infused cells may make enough insulin that they no longer need to use insulin to control sugar levels.
Donislecel-based therapy was tested in two non-randomised, single-arm studies involving a total of 30 patients who had difficulty detecting the onset of hypoglycemia. Participants were given at least one infusion and up to three. Of the 30 patients, 21 were without insulin for at least one year, 11 did not need insulin for between one and five years, 10 were without insulin for more than five years. Five patients did not achieve any days of insulin independence.
Cell therapy appears to be in development as a viable treatment for type 1 diabetes. Vertex on Friday announced one-year follow-up data from a Phase I/II clinical trial of its investigational cell-based therapy VX-880 stem cells, demonstrating that two patients no longer needed insulin injections.
VX-880 is an allogeneic stem cell therapy that delivers fully differentiated, insulin-producing islets to restore the body’s ability to produce insulin in response to glucose.
Both patients on the therapy experienced large reductions in hemoglobin A1c (HbA1c) one year after receiving the investigational cell therapy and spent 95 percent of the time within the reference range of blood glucose levels, Vertex reported. L’American Diabetes Association recommends that patients with type 1 diabetes spend at least 70% of their time within this range.
Nurse Times editorial team
Font: PharmaStar
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